Cannula with image markers to indicate expandable size device

ABSTRACT

A cannula and method include a shaft portion having a proximal end, a distal end, a longitudinal axis and a lumen extending from the proximal end to the oppositely disposed distal end along the longitudinal axis. A hub is attached to the proximal end of the shaft portion and includes a transverse portion, which extends transversely relative to the longitudinal axis of the shaft portion. An opaque marker is disposed on the transverse portion at a position corresponding to an expanded size of an expandable element such that the opaque marker indicates the expanded size in an imaging system image.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of application U.S. patent applicationSer. No. 13/773,227, filed on Feb. 21, 2013, which is expressly herebyincorporated by reference herein, in its entirety.

TECHNICAL FIELD

The present disclosure provides cannulas for use in surgical proceduresand, more particularly, to a cannula configured with markers to indicatean extent of balloon inflation in medical images. Methods of using sucha cannula are also provided.

BACKGROUND

During minimally invasive surgical procedures, cannulas are utilized toprovide an access port for surgical instruments and for treatingconditions such as fractures. A sharp trocar may be positioned withinthe cannula and utilized to puncture or pierce the tissue to accessdamaged bone. Thereafter, the trocar may be removed, leaving the cannulain place providing the access port to the site of treatment.Stabilization of the cannula during treatment is very important, as theports can be accidentally ejected from the patient or moved whilematerials, such as bone cement, are being delivered resulting in lessperfect treatment and increased procedure time.

Where there is minimal cancellous bone, such as a distal radius, whenthe cannula is inserted, it cannot be easily stabilized and may notremain stationary. This destabilization can cause imprecise disbursementof material, such as bone cement. In addition, during a procedure,instruments inserted into a patient may not always be visible to ensureproper alignment with instruments and/or anatomical features.

SUMMARY

This application relates to cannula systems and methods of use. Inaccordance with the present principles, a cannula system includes ashaft portion having a proximal end, a distal end, a longitudinal axisand a lumen extending from the proximal end to the oppositely disposeddistal end along the longitudinal axis. A hub is attached to theproximal end of the shaft portion and includes a transverse portion,which extends transversely relative to the longitudinal axis of theshaft portion. An opaque marker is disposed on the transverse portion ata position corresponding to an expanded size of an expandable elementsuch that the opaque marker indicates the expanded size in an imagingsystem image.

In another embodiment, a cannula includes a shaft portion having aproximal end, a distal end, a longitudinal axis and a lumen extendingfrom the proximal end to the oppositely disposed distal end along thelongitudinal axis, the shaft portion including a scoop formed at thedistal end for supporting a balloon. A hub is attached to the proximalend of the shaft portion and includes a transverse portion, whichextends transversely relative to the longitudinal axis of the shaftportion. Radiopaque markers are disposed on the transverse portion atpositions corresponding to an expanded size of the balloon wherein oneof the markers is located on the hub at a position corresponding to thescoop of the shaft portion and another marker is located on the hub at aposition corresponding to an opposite side of the balloon from the scoopsuch that the radiopaque markers indicate the expanded size in animaging system image. One or more holes are formed through the hub inthe longitudinal direction, and the holes are configured to receive astabilizing device.

A treatment method includes providing a cannula having a shaft portionhaving a proximal end, a distal end, a longitudinal axis and a lumenextending from the proximal end to the oppositely disposed distal endalong the longitudinal axis; a hub attached to the proximal end of theshaft portion and including a transverse portion which extendstransversely relative to the longitudinal axis of the shaft portion; andat least one opaque marker disposed on the transverse portion at aposition corresponding to an expanded size of an expandable element;aligning the expandable element with the shaft portion; expanding theexpandable element to the expandable size; and imaging the hub such thatthe at least one opaque marker indicates the expanded size in an imagingsystem image.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of a cannula having a scoop formed on adistal end portion in accordance with the principles of the presentdisclosure;

FIG. 2 is a perspective view of a trocar to be employed with the cannulaof FIG. 1 in one particular embodiment;

FIG. 3 is a perspective view of the cannula of FIG. 1 having the trocarof FIG. 2 attached thereto in accordance with one illustrativeembodiment;

FIG. 4A is an end view showing a cannula hub and a balloon schematicallyshown to demonstrate marker positions relative to the balloon inaccordance with one embodiment;

FIG. 4B is a side view showing the cannula hub and the balloon of FIG.4A to demonstrate marker positions relative to the balloon in accordancewith one embodiment;

FIG. 5A is an end view showing an asymmetric cannula hub and a balloonschematically shown to demonstrate marker positions relative to theballoon in accordance with another embodiment;

FIG. 5B is a side view showing the cannula hub and the balloon of FIG.5A to demonstrate marker positions relative to the balloon, a shaft ofthe cannula having a scoop support an end of the balloon in accordancewith another embodiment;

FIG. 6 is an end view showing a cannula hub having symmetricallydisposed markers and holes configured to receive stabilizing devices inaccordance with one embodiment;

FIG. 7 is an end view showing a cannula hub having asymmetricallydisposed markers corresponding to a scoop arrangement for the cannulaand holes configured to receive stabilizing devices in accordance withanother embodiment; and

FIG. 8 is an end view showing a cannula hub having asymmetricallydisposed markers corresponding to a scoop arrangement for the cannulaand having holes configured to receive stabilizing devices, one markerbeing shaped to provide an orientation of the scoop in accordance withyet another embodiment.

Like reference numerals indicate similar parts throughout the figures.

DETAILED DESCRIPTION

An apparatus and method are described for a cannula having markers on ahandle that indicate a dimension or potential dimension of a balloonemployed at a distal end portion of the cannula. For illustrativepurposes, the apparatus and method shall be described in the context ofpositioning expandable balloons in a long bone or vertebra of a patientto treat bone fractures, although the apparatus and methods can be usedto treat other conditions.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, distaland proximal, are for illustrative purposes only and can be variedwithin the scope of the disclosure. For example, the references “upper”and “lower” are relative and used only in the context to the other, andare not necessarily “superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), in an effort toalleviate signs or symptoms of the disease or condition. Alleviation canoccur prior to signs or symptoms of the disease or condition appearing,as well as after their appearance. Thus, treating or treatment includespreventing or prevention of disease or undesirable condition (e.g.,preventing the disease from occurring in a patient, who may bepredisposed to the disease but has not yet been diagnosed as having it).In addition, treating or treatment does not require complete alleviationof signs or symptoms, does not require a cure, and specifically includesprocedures that have only a marginal effect on the patient. Treatmentcan include inhibiting the disease, e.g., arresting its development, orrelieving the disease, e.g., causing regression of the disease. Forexample, treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligamentand/or bone, repairing a fracture or break in bone and other tissues; asan adjunct in surgery; and/or any repair procedure. Also, as used in thespecification and including the appended claims, the term “tissue”includes soft tissue, ligaments, tendons, cartilage and/or bone unlessspecifically referred to otherwise.

The following disclosure includes a description of a cannula and systemfor treating fractures, including using an inflatable bone tamp,employing drills and delivering bone void filler, such as, for example,autograft, allograft, demineralized bone matrix, mineral composites,blocks, granules and pellets and bone cement, such as, for example,polymethylmethacrylate (PMMA)-based material (Kyphon HV-R, ActivOs,ActivOs 10, Xpede), calcium phosphate (Skaffold, Norian, Hydroset,KyphOs FS) and calcium sulfate (OsteoSet), as well as other injectables.The disclosure also includes a description of related methods ofemploying the cannula in accordance with the principles. Alternateembodiments are also disclosed. Reference will now be made in detail tothe exemplary embodiments of the present disclosure, which areillustrated in the accompanying figures. Turning now to FIGS. 1-8 ,there are illustrated components of a cannula device or cannula 10 inaccordance with the principles of the present disclosure.

The components of the cannula 10 can be fabricated from biologicallyacceptable materials suitable for medical apparatuses, including metals,synthetic polymers, ceramics, thermoplastic and polymeric materialand/or their composites. For example, the components of the cannula 10,individually or collectively, can be fabricated from materials such asstainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (e.g., Nitinol,super elasto-plastic metals, such as GUM METAL® manufactured by ToyotaMaterial Incorporated of Japan, Fe—Mn—Si and Fe—Ni—Co—Ti composites),ceramics and composites thereof such as calcium phosphate (e.g.,SKELITE™ manufactured by Biologix™, Inc.), thermoplastics such aspolyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymersbased materials, polymeric rubbers, polyolefin rubbers, semi-rigid andrigid materials, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, polyacrylateand composites of metals and calcium-based ceramics, composites of PEEKand calcium based ceramics, and combinations of the above materials.Various components of the cannula 10 may have material composites,including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance, andbiomechanical performance, durability and to provide a non-sticksurface. The components of the cannula 10 may be monolithically formed,integrally connected or include fastening elements and/or couplingcomponents, as described herein. The cannulas as described herein may bedisposable or may be autoclavable or resterilizable. The cannulas andaccessories may be part of a kit.

As will be described fully herein, one embodiment of the presentdisclosure incorporates and utilizes one or more material(s), whichexhibit radiopacity. These may include markers or portions of a handleof the cannula 10. Radiopacity refers to the relative inability ofelectromagnetic radiation, particularly X-rays, to pass through aparticular material. Examples of radiopaque materials include, metals,such as stainless steel, titanium, tungsten, or materials that includebarium or zirconium, e.g., barium sulfate, zirconium oxide,respectively.

In one embodiment, as shown in FIG. 1 , cannula 10 includes a handleportion 26 and a shaft portion 12 extending along a longitudinal axis L.In this embodiment, cannula 10 includes a distal end portion 18 that isformed to resemble a scoop or channel 14. The shaft portion 12 is hollowforming a cavity or lumen 28. A portion of the shaft portion 12 isremoved or formed at the end portion 18 to provide the scoop 14. Thecavity 28 passes through the entire shaft portion 12 and through ahandle portion or hub 26 so that tools and instruments may be threadedtherethrough. The handle portion 26 includes an opening at a proximalend portion 24. The proximal end portion 24 forms a port that may beconfigured to interlock with various tools and instruments for carryingout a procedure. To this end, portion 24 may include various clips,protrusions detents, etc. to mate with and secure the various tools orinstruments (e.g., a trocar).

The handle portion 26 includes structures 22 that extend transverselyfrom a longitudinal axis of the shaft portion 12. In accordance with thepresent principles, the structures 22 are configured and dimensioned tobe larger than or equal to a size of a balloon (not shown) at its fullyextended position (e.g., the hub 26 or structures 22 will indicate thesize of the balloon at maximum inflation volume (MIV). This may beimplemented in either uni-directional or omni-directional balloonexpansion approaches. In either case, the structures 22 extend outwardlyto at least the extend of the MIV or beyond the MIV. Although thestructures 22 are depicted as “wings” or bars, the structures 22 mayinclude a plurality of different shapes or combinations of shapes. Forexample, the structures 22 may include semicircles, may be part of afull circle, may be cylindrical, may be part of a star shape, etc.

Markers 20 are mounted on, detachably connected or integrally formed inthe handle portion 26 on the structures 22. A location of the markers 20may correspond to the MIV of the balloon employed with the cannula 10during a procedure. It should be understood that the markers 20 might beplaced at any other location that provides a beneficial result. In oneembodiment, the position of the markers 20 may be adjustable on thestructures 22. The markers 20 include radiopaque or other material thatcreates visibility in images such that during a procedure, the markers20 will appear in images to indicate a boundary or other distance for aposition of the balloon or other instrument to be known. The images maybe taken using fluoroscopy, although other imaging techniques (e.g.,computed tomography, magnetic resonance, etc.) may be employed. Itshould be understood that additional markers might be placed on thehandle portion 26 as needed or desired.

Referring to FIG. 2 with continued reference to FIG. 1 , a trocar 30 isillustratively depicted that is configured for use with the cannula 10depicted in FIG. 1 . Trocar 30 is employed for initially piercing tissueto insert the cannula 10 inside a patient. In one embodiment, a solidshaft 32, which includes a pointed end 34, is inserted into the hollowshaft portion 12 of the cannula 10. The shaft 32 is fully inserted intothe shaft portion 12 until a surface 16 (FIG. 1 ) of the handle portion26 engages a surface 40 of a trocar handle 36. Clips 38 mate withportions of the handle portion 26 to detachably connect the handleportion 26 to the trocar handle 36. The assembled cannula 10 withinserted trocar 30 is depicted in FIG. 3 . After the trocar 30 isemployed to insert the cannula 10 into the patient, the trocar 30 isremoved permitting the cavity 18 to receive other tools or devices. Suchtools or devices may include a balloon or the like.

Referring to FIGS. 4A and 4B, a proximal end view and a side view of acannula 100 are respectively shown. FIGS. 4A and 4B include a fullyinflated balloon 108 schematically shown to provide a relativemeasurement as will be described.

FIG. 4A shows a hub or handle portion 104 of the cannula 100 with aballoon 108 schematically depicted at MIV looking in a distal directionlongitudinally along a cannula bore 102. The handle portion 104 extendstransversely (radially outward) from the cannula bore 102 to asufficient distance to be equal to or greater than the balloon 108 atMIV. Markers 106 are mounted on or integrally formed in the handleportion 104 at positions corresponding with the MIV position of theballoon 108.

FIG. 4B shows a side view of the cannula 100 with the balloon 108schematically depicted to demonstrate the positional relationshipbetween boundaries of the balloon 108 and the markers 106. In thisembodiment, a shaft 112 does not include a scoop and is uniform aboutits tip portion. The center of the balloon 108 substantially correspondswith a center of the lumen of the shaft 112. Extents of the balloon 108at MIV are indicated by lines 114. Balloon expansion is omni-directionalin this example.

During a procedure, a trocar (e.g., FIG. 3 ) may be inserted into thecannula 100, and the system is inserted through tissue to reach, e.g., abone or other target. The trocar is then removed. The balloon 108,connected to its inflation tube (not shown), may be inserted into a port110 and fed through the shaft 112. Alternately, the balloon 108 may beinserted through a different port and aligned with the cannula 100. Theballoon 108 is positioned and inflated as needed in accordance with thepresent procedure.

Referring to FIGS. 5A and 5B, a proximal end view and a side view of acannula 200 are respectively shown. FIGS. 5A and 5B include a fullyinflated balloon 208 schematically shown to provide a relativemeasurement as will be described.

FIG. 5A shows a hub or handle portion 204 of the cannula 200 with aballoon 208 schematically depicted at MIV looking in a distal directionlongitudinally along a cannula bore 202. The handle portion 204 extendstransversely (radially outward) from the cannula bore 202 to asufficient distance to be equal to or greater than the balloon 208 atMIV. Markers 206 are mounted on or integrally formed in the handleportion 204 at a position corresponding with the MIV position of theballoon 208.

In this embodiment, cannula 200 includes a scoop 220, which aids inmaking the balloon 208 uni-directional, e.g., toward a fracturedarticular surface. The scoop 220 supports the balloon 208, therefore,providing a bound to its lower position. This is in contrast with theapproach depicted with omni-directional expansion of the balloon 108 inFIGS. 4A and 4B.

FIG. 5B shows a side view of the cannula 200 with the balloon 208schematically depicted to demonstrate the positional relationshipbetween boundaries of the balloon 208 and the markers 206. In thisembodiment, a shaft 212 includes the scoop 220, such that the center ofthe balloon 208 is offset from a center of the lumen of the shaft 212.Extents of the balloon 208 at MIV are indicated by a line 214 at anupper position of the balloon 208 at MIV and by the scoop 220 at a lowerposition of the balloon 208 at MIV. The upper position is offset by agreater distance d₁ than the side with the scoop 220 to provide theuni-directional inflation growth of the balloon 208.

In this embodiment, the handle portion 204 is asymmetrically disposedabout the cannula bore 202. One marker 206 is located at a lowerposition of the balloon 208 corresponding with the scoop 220. Anothermarker 206 corresponds with the upper position indicated by line 214.

During a procedure, a trocar (e.g., FIG. 3 ) may be inserted into thecannula 200. The trocar is then removed. The balloon 208, connected toits inflation tube (not shown), may be inserted into a port 210 and fedthrough the shaft 212. Alternately, the balloon 208 may be insertedthrough a different port and aligned with the cannula 200. The balloon208 is positioned and inflated as needed in accordance with the presentprocedure. In this embodiment, the scoop 220 aids in making the balloon208 uni-directional towards a fractured articular surface or otherstructure, where the scoop 220 supports the balloon 208. In oneparticularly useful embodiment, the markers 206 are radiopaqueindicators in the hub or handle portion 204 and indicate a maximuminflated diameter of inflatable bone tamps (IBT's) in fluoroscopicimages.

FIGS. 6-8 schematically show different illustrative configurations forthe hub or handle portion (e.g., 26, 104, 204) in accordance with thepresent principles. Referring to FIG. 6 , a hub or handle portion 304includes a cannula bore 302 having markers 306 each disposed an equaldistance from the bore 302. The markers 306 may include radiopaque pins,dots, bars, etc. This configuration corresponds to the embodiment wherea balloon and the bore 302 have centers that substantially line up whenthe balloon is inflated (see e.g., hub 104 in FIGS. 4A and 4B). The hubor handle portion 104 includes holes 310 formed therethrough. The holes310 are configured for receiving a support or stabilization device orstructure, such as, e.g., a k-wire. In one embodiment, k-wires may beemployed to prevent rotation or movement of the cannula during use. Ak-wire or wires (not shown) may be threaded through the holes 310 andattached to bone or other structures to prevent pull-out or rotation ofthe hub during a procedure.

Referring to FIG. 7 , a hub or handle portion 404 includes a cannulabore 402 having markers 406 each disposed an unequal distance from thebore 402. This configuration corresponds to the embodiment, whichemploys a scoop where a balloon and the bore 402 have centers that areoffset when the balloon is inflated (see e.g., hub 204 in FIGS. 5A and5B). The hub or handle portion 404 includes holes 410 formedtherethrough. The holes 410 are configured for receiving a supportdevice or structure, such as, e.g., a k-wire. In one embodiment, k-wiresmay be employed to prevent rotation or movement of the cannula duringuse. A k-wire or wires (not shown) may be threaded through the holes 410and attached to bone or other structures to prevent pull-out or rotationof the hub during a procedure. While FIG. 7 depicts the holes 410 ascorresponding to a distance beyond a diameter of an inflated balloon(not shown), holes 410 may be set apart an equal distance from thecannula bore 402. Adjustment of the size of the hub 404 to accommodatethis or any other distance desired between the holes 410 may be designedinto the hub 404. The holes 410 may have any distance therebetween. Inaddition, the number of holes 410 need not be two and one or more holes410 may be employed.

Referring to FIG. 8 , a hub or handle portion 504 includes a cannulabore 502 having markers 506 and 512 each disposed an unequal distancefrom the bore 502. This configuration corresponds to the embodiment,which employs a scoop where a balloon and the bore 502 have centers thatare offset when the balloon is inflated (see e.g., hub 204 in FIGS. 5Aand 5B). The hub or handle portion 504 includes holes 510 formedtherethrough. The holes 510 are configured for receiving a supportdevice or structure, such as, e.g., a k-wire. A k-wire(s) may beemployed to prevent rotation or movement of the cannula during use.While FIG. 8 depicts the holes 510 as corresponding to a particulardistance, other distances between the holes 510 may be provided. Inaddition, the number of holes 510 need not be two and one or more holes510 may be employed. The hub size may be fabricated to accommodate theneeded distances between the holes 510.

In this embodiment, the marker 512 is shaped to correspond to a positionand shape of the scoop 220 (FIG. 5B). Marker 512 is configured toindicate the position and extent of the scoop portion of the cannula.Marker 512 includes a radiopaque material mounted on or integrated intothe hub 504 to show both the maximum inflated diameter of a balloon (orother size) and the scoop cannula configuration such that the marker 512provides additional information about a position and orientation of thescoop portion in fluoroscopic images. It should be understood that otherconfigurations and shapes of markers may be provided to provide abenefit for a given application. In addition, any number of markers andany shape of marker may be employed in accordance with the presentprinciples.

The cannulas depicted in FIGS. 1-8 may take many forms. It iscontemplated that the cannulas may be configured in a number of ways andinclude different shaped handle portions, such as, for example, round,oval, oblong, square, rectangular, polygonal, irregular, uniform,non-uniform, offset, staggered, tapered, consistent or variable,depending on the requirements of a particular application. An outersurface of the handle portions of the cannulas may be rough, arcuate,undulating, mesh, porous, semi-porous, dimpled and/or textured accordingto the requirements of a particular application.

Shaft portions of the cannulas may include a lumen that can be variouslyconfigured and have a cross-section that is, for example, round, oval,oblong, square, rectangular, polygonal, irregular, uniform, non-uniform,offset, staggered, tapered, consistent or variable, depending on therequirements of a particular application. In one embodiment, inaccordance with the disclosure, it is contemplated that the cannulasinclude a cutting edge at a distal end configured to cut into thetissue. In the alternative, the distal end may include a threadedportion, fluted tip as well as other surgical configurations. In anotheralternative, a separate device can be used to cut a primary access portfor the cannula (e.g., a trocar).

In assembly and use, cannulas are employed in a surgical procedure fortreatment of a disorder affecting a section of bone, such as a fracture,for example in the distal radius, tibial plateau or proximal humerus ofa patient, as described herein. In use, to treat the affected section, amedical practitioner obtains access to the bone in any appropriatemanner, which may include incision and retraction of tissues. Once thebone is exposed the cannula can be used to create and enter an accessport adjacent to a fracture to be treated. It is envisioned that cannulamay be used in any existing surgical method or technique including opensurgery, mini-open surgery, minimally invasive surgery and percutaneoussurgical implantation, whereby the site is accessed through amicro-incision, or sleeve that provides a protected passageway to thearea. Once access to the surgical site is obtained, the cannula can bedeployed so as to deliver an agent, such as bone void filler/bonecement, to treat the condition, such as repair the fracture.

In one particular embodiment, use of the cannula is delivered into thesurgical site adjacent to a fracture or a break in a portion of a bonesuch as the distal radius, tibial plateau or proximal humerus as well asother bone sites. These bone sites have minimal cancellous bone, andtherefore, when the cannula is inserted, it cannot be easily stabilizedand does not remain stationary. This unstabilization can cause imprecisedisbursement of material, such as bone void filler/bone cement. Tofacilitate stabilization of the cannula, a balloon may be used and whendeployed is disposed between an expanded configuration and an unexpandedconfiguration. When the cannula is inserted into the surgical site, theexpanded configuration portion is in its unexpanded configuration withinthe cannula. As the balloon exits a distal end of the cannula, theexpanded configuration is achieved by filling the balloon. The expandedconfiguration stabilizes the cannula in place by pressing against theexisting cancellous bone thereby allowing for precise delivery of bonevoid filler/bone cement, or deployment of other agents and/or surgicaltools that may be required. The scoop portion of the cannula aids inmaking the expanded unidirectional towards a fractured articularsurface. In other words, the scoop supports the expanded balloon in adesired direction. For further stability, k-wires may be employed asdescribed to stabilize the cannula. The balloon is deflated to retractit back into the cannula, and the cannula system can be removed.

It is contemplated that in addition to supporting the expanded balloonin a particular direction, the scoop cannula can be sued to provide bonevoid filler/bone cement, as well as other to a surgical site. Theseagents include therapeutic polynucleotides or polypeptides. It isfurther contemplated that these agents may also include biocompatiblematerials, such as, for example, biocompatible metals and/or rigidpolymers, such as, titanium elements, metal powders of titanium ortitanium compositions, sterile bone materials, such as allograft orxenograft materials, synthetic bone materials such as coral and calciumcompositions, such as hydroxyapatite (HA), calcium phosphate and calciumsulfate, biologically active agents, for example, gradual releasecompositions such as by blending in a bioresorbable polymer thatreleases the biologically active agent or agents in an appropriate timedependent fashion as the polymer degrades within the patient. Suitablebiologically active agents include, for example, Bone MorphogeneticProteins (BMP), Growth Differentiation Factors (GDF) and cytokines. Thecomponents of the cannula can be made to include radiolucent materialssuch as polymers. Radiomarkers may be included for identification underx-ray, fluoroscopy, CT or other imaging techniques. It is envisionedthat the agent may include one or a plurality of therapeutic agentsand/or pharmacological agents for release, including sustained release,to treat, for example, pain, inflammation and degeneration.

It is envisioned that the use of microsurgical and image guidedtechnologies may be employed to access, view and repair bonedeterioration or damage, in conjunction with the cannula. The markerposition may include the MIV of the balloon. However, other positionsand reference points may be employed. For example, a half-filled orquarter-filled balloon position may be indicated use the positionmarkers described herein.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A treatment method, comprising: providing acannula having a shaft portion having a proximal end, a distal end, alongitudinal axis and a lumen extending from the proximal end to theoppositely disposed distal end along the longitudinal axis, a hubattached to the proximal end of the shaft portion and including atransverse portion which extends transversely relative to thelongitudinal axis of the shaft portion, and at least one opaque markerdisposed on the transverse portion at a position corresponding to anexpanded size of an expandable element; aligning the expandable elementwith the shaft portion; expanding the expandable element to the expandedsize; and imaging the hub such that the at least one opaque markerindicates the expanded size in an imaging system image.
 2. A method asin claim 1, further comprising a scoop on the distal end of the shaftportion for contacting the expandable element, the at least one opaquemarker including two markers, one marker being located on the hub at aposition corresponding to the scoop of the shaft portion and another ofthe two markers being located on the hub at a position corresponding toan opposite side of the balloon from the scoop.
 3. A method as in claim2, wherein the marker located on the hub at the position correspondingto the scoop includes a shape for indicating an orientation of thescoop.
 4. A method as in claim 2, wherein the marker located on the hubat the position corresponding to the opposite side of the balloon fromthe scoop does not overlap the marker located on the hub at the positioncorresponding to the scoop in a longitudinal direction.
 5. A method asin claim 2, wherein: the marker located on the hub at the positioncorresponding to the scoop includes a shape for indicating anorientation of the scoop; and the marker located on the hub at theposition corresponding to the opposite side of the balloon from thescoop does not overlap the marker located on the hub at the positioncorresponding to the scoop in a longitudinal direction.
 6. A method asin claim 1, further comprising a scoop on the distal end of the shaftportion for contacting the expandable element, the at least one opaquemarker including a first marker, a second marker, and a third marker,the first marker being disposed on the transverse portion at theposition corresponding to the expanded size of the expandable element,the second marker being located on the hub at a position correspondingto the scoop of the shaft portion, the third marker being located on thehub at a position corresponding to the distal end.
 7. A method as inclaim 6, wherein the second marker includes a shape for indicating anorientation of the scoop.
 8. A method as in claim 6, wherein the firstmarker, the second marker, and the third marker do not overlap in alongitudinal direction.
 9. A method as in claim 6, wherein: the secondmarker includes a shape for indicating an orientation of the scoop; andthe first marker, the second marker, and the third marker do not overlapin a longitudinal direction.
 10. A treatment method, comprising:providing a cannula comprising: a shaft extending along a longitudinalaxis between a proximal end and an opposite distal end, the distal endincluding an end portion forming a scoop, a balloon having an outersurface with opposite first and second sides, the first side beingsupported by the scoop, and a hub attached to the proximal end, the hubincluding a transverse portion extending transverse to the longitudinalaxis, the transverse portion including a first marker located at aposition corresponding to the scoop, the transverse portion including asecond marker located at a position corresponding to the second side;and imaging the hub such that the first marker indicates a position ofthe scoop in an imaging system and the second marker indicates aposition of the second side in the imaging system.
 11. A method as inclaim 10, wherein the balloon is movable between an unexpandedconfiguration and an expanded configuration in which the balloon has anexpanded size, the second marker being located at the positioncorresponding to the second side when the balloon is in the expandedconfiguration.
 12. A method as in claim 10, wherein the first markerincludes a shape for indicating an orientation of the scoop.
 13. Amethod as in claim 10, wherein the first marker does not overlap thesecond marker in a longitudinal direction.
 14. A method as in claim 10,wherein the markers are fixed relative to the shaft.
 15. A method as inclaim 10, wherein the markers are each disposed in a transverse plane.16. A method as in claim 10, wherein the markers create visibilities inthe imaging system, the visibilities being spaced apart from one anotherwhen viewed along the longitudinal axis.
 17. A method as in claim 10,wherein the markers are opaque.
 18. A method as in claim 10, wherein themarkers are radiopaque.
 19. A method as in claim 10, wherein the markersare disposed at substantially equal distances from the shaft.
 20. Atreatment method, comprising: providing a cannula comprising: a shaftextending along a longitudinal axis between a proximal end and anopposite distal end, the distal end including an end portion forming ascoop, a balloon having an outer surface with opposite first and secondsides, the first side being supported by the scoop, the balloon ismovable between an unexpanded configuration and an expandedconfiguration in which the balloon has an expanded size, and a hubattached to the proximal end, the hub including a transverse portionextending transverse to the longitudinal axis, the transverse portionincluding a first radiopaque marker located at a position correspondingto the scoop, the first radiopaque marker including a shape forindicating an orientation of the scoop, the transverse portion includinga second radiopaque marker located at a position corresponding to thesecond side when the balloon is in the expanded configuration, thesecond radiopaque marker not overlapping the first radiopaque marker ina longitudinal direction; moving the balloon from the unexpandedconfiguration to the expanded configuration; and imaging the hub suchthat the first marker indicates a position and orientation of the scoopin an imaging system and the second marker indicates a position of thesecond side in the imaging system.